Study Status

Parameter Value
Unique Study ID AA-AA-000-0000
Protocol title Protocol Title
Protocol nickname Protocol Nickname
Sites (Enrolled / Planned) 176 / 190
Participants (Enrolled / Planned) 1301 / 1300
Parameter Value
Unique Study ID AA-AA-000-0000
Protocol title Protocol Title
Protocol nickname Protocol Nickname
Sites (Enrolled / Planned) 176 / 190
Participants (Enrolled / Planned) 1301 / 1300
Date that snapshot was created 2023-11-02
Risk-based monitoring flag Y
Study Status Active
Product Product
Phase P3
Therapeutic Area Therapeutic Area
Indication Protocol Indication
Protocol type Investigator Sponsored
Protocol row ID 1-1G9113
Protocol product number 123
# of enrolled sites from GILDA 176
# of enrolled participants from GILDA 1301
First-patient first visit date 2003-01-01
Estimated first-patient first visit date from GILDA 2003-01-01
Last-patient first visit date 2020-06-01
Estimated last-patient first visit date from GILDA 2020-06-01
Last-patient last visit date 2021-06-01
Estimated last-patient last visit date from GILDA 2021-06-01
Average snapshot interval 578.6 days
Median snapshot interval 365 days

Study Overview

24 Red KRIs

65 Amber KRIs

As of 2023-11-02, AA-AA-000-0000 has 1301 participants enrolled across 176 sites. 24 Site-KRI combinations have been flagged as red across 16 sites as shown in the Study Overview Table above

  • 16 sites have at least one red KRI

  • 60 sites have at least one red or amber KRI

  • 116 sites have neither red nor amber KRIs and are not shown

Results

AE Reporting Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

SAE Reporting Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Non-important PD Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Important PD Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

G3+ Lab Abnormality Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Study Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Treatment Discontinuation Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Query Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Outstanding Query Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Outstanding Data Entry Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Data Change Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

Screen Failure Rate

Summary Charts

Scatter Plot
Bar Chart (KRI Metric)
Bar Chart (KRI Score)
Time Series (Continuous)

Summary Table

KRI Glossary

Error Log

Inactive KRI’s

No Inactive KRI’s